NCT07774390 Ibrutinib Plus Venetoclax Long-Term Outcomes in CLL
| NCT ID | NCT07774390 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Research Initiative on CLL |
| Condition | Chronic Lymphocytic Leukemia (CLL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 323 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 323 participants in total. It began in 2025-12-18 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is focused on tracking the long-term health of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial. Purpose and Goals While new treatments have significantly improved survival for patients with CLL, the disease remains incurable and often requires multiple rounds of treatment over a person's life. The primary goal of this study is to understand what happens to patients after they have completed their initial (frontline) treatment with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial. Researchers specifically want to: * Identify the types and frequency of "second-line" treatments patients receive if their disease returns. * Assess the long-term safety and effectiveness of the initial ibrutinib and venetoclax treatment. * Study how the disease might become resistant to these treatments over time. Who Can Participate? The study is specifically for individuals who were previously enrolled in the original CAPTIVATE study. Only patients at participating medical centers who provide their informed consent can join. Study Methods and Procedures This is an observational study, meaning researchers will monitor patients' health during their routine medical care rather than testing a new, experimental treatment. Key aspects of the study include: * Long-Term Monitoring: Patients will be followed for up to 10 years. * Data Collection: Researchers will collect information on disease status, treatment history, new health issues (comorbidities), and survival. * Optional Testing: With additional consent, patients may provide blood samples every six months to check for "measurable residual disease" (MRD)-very small amounts of cancer cells that remain after treatment. * Genetic Analysis: If a patient's CLL progresses, researchers may analyze blood samples to look for specific genetic mutations that might explain why the treatment stopped working. Participation is entirely voluntary, and patients can choose to withdraw from the study or opt out of specific tests (like blood sampling) at any time without affecting their standard medical care.
Eligibility Criteria
Individuals who meet all of the inclusion criteria will be eligible to participate in the study. 1. Participant is willing and able to give informed consent for participation in this study. 2. Previously enrolled into the CAPTIVATE study. 3. Being treated in a center that has agreed to participate in this follow-up study. Exclusion Criteria: The only exclusion criterion of this study: 1\. Inability or refusal to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07774390 clinical trial?
This trial is open to participants of all sexes, studying Chronic Lymphocytic Leukemia (CLL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07774390 currently recruiting?
Yes, NCT07774390 is actively recruiting participants. Contact the research team at ghia.paolo@hsr.it for enrollment information.
Where is the NCT07774390 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07774390 clinical trial?
NCT07774390 is sponsored by European Research Initiative on CLL. The trial plans to enroll 323 participants.
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